Informations générales (source: ClinicalTrials.gov)
A Phase 2 Trial of Combination Therapies With Adagrasib in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
Interventional
Phase 2
Mirati Therapeutics Inc. (Voir sur ClinicalTrials)
novembre 2022
décembre 2026
10 octobre 2024
Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical
efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the
first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS <50% and KRAS G12C
mutation
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Christos CHOUAID | 17/12/2024 09:44:16 | Contacter | ||
| CLCC INSTITUT GUSTAVE ROUSSY | Fabrice BARLESI | 05/06/2024 10:54:06 | Contacter | ||
| HOPITAL FOCH | Jaafar BENNOUNA | 23/12/2024 08:04:35 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Tenon | Jacques Cadranel, Site 017-686 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Francois Baclesse - 14076 - Caen Cedex 5 - France | Hubert CURCIO, Site 017-196 | Contact (sur clinicalTrials) | |||
| Centre Georges Francois Leclerc - 21079 - Dijon cedex - France | Coureche Kaderbhai, Site 017-192 | Contact (sur clinicalTrials) | |||
| Hopital Larrey - 31059 - Toulouse cedex 9 - France | Julien Mazieres, Site 017-663 | Contact (sur clinicalTrials) | |||
| Hopital Michallon - 38700 - La Tronche - France | Denis Moro-Sibilot, Site 017-683 | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie de lOuest - Angers - 49055 - Angers Cedex 02 - France | Frederic Bigot, Site 017-689 | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - 13009 - Marseille - France | Anne Madroszyk-Flandin, Site 017-199 | Contact (sur clinicalTrials) | |||
| Local Institution - 017-198 - 44805 - Saint Herblain - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 017-200 - 34090 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 017-664 - 75248 - Paris cedex 05 - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 017-688 - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| Local Institution - Unk029 - 75018 - Paris - France | Contact (sur clinicalTrials) | ||||
| Local Institution - Unk067 - 13015 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Local Institution - Unk078 - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Cohort A* (closed): Has an untreated and unresectable or metastatic NSCLC with
histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically
confirmed PD-L1 TPS ≥1%.
- Cohort C: Has an untreated and unresectable or metastatic NSCLC with histologically
confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1
TPS < 50% AND previously completed 4 cycles of standard-of-care platinum based
induction chemotherapy with pembrolizumab AND experienced stable disease, partial
response, or complete response per investigator's assessment after 4 cycles OR if
patients received <4 cycles of a platinum-based induction, was stopped early due to
intolerable toxicity
- Cohort E: Has an untreated and unresectable or metastatic NSCLC with histologically
confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1
TPS < 50%
- Presence of measurable disease per RECIST v1.1
Exclusion Criteria:
- All Cohorts: Any prior therapy targeting KRASG12C mutation in any setting
- Cohorts A & E: Prior systemic therapy for locally advanced or metastatic NSCLC,
including chemotherapy, immune checkpoint inhibitor therapy or chemoimmunotherapy
(note: prior systemic therapy or chemoradiation given in the adjuvant or neoadjuvant
setting are allowed if last dose of prior systemic treatment was >1 year prior to
first dose of study treatment)
- Cohort C: received maintenance therapy (e.g, pembrolizumab and/or pemetrexed
following completion of 4-6 cycles of a platinum-based regimen administered in the
first-line setting
- Radiation to the lung > 30 Gy within 6 months prior to first dose of study treatment
- Active brain metastases
histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically
confirmed PD-L1 TPS ≥1%.
- Cohort C: Has an untreated and unresectable or metastatic NSCLC with histologically
confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1
TPS < 50% AND previously completed 4 cycles of standard-of-care platinum based
induction chemotherapy with pembrolizumab AND experienced stable disease, partial
response, or complete response per investigator's assessment after 4 cycles OR if
patients received <4 cycles of a platinum-based induction, was stopped early due to
intolerable toxicity
- Cohort E: Has an untreated and unresectable or metastatic NSCLC with histologically
confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1
TPS < 50%
- Presence of measurable disease per RECIST v1.1
Exclusion Criteria:
- All Cohorts: Any prior therapy targeting KRASG12C mutation in any setting
- Cohorts A & E: Prior systemic therapy for locally advanced or metastatic NSCLC,
including chemotherapy, immune checkpoint inhibitor therapy or chemoimmunotherapy
(note: prior systemic therapy or chemoradiation given in the adjuvant or neoadjuvant
setting are allowed if last dose of prior systemic treatment was >1 year prior to
first dose of study treatment)
- Cohort C: received maintenance therapy (e.g, pembrolizumab and/or pemetrexed
following completion of 4-6 cycles of a platinum-based regimen administered in the
first-line setting
- Radiation to the lung > 30 Gy within 6 months prior to first dose of study treatment
- Active brain metastases